Trials / Completed
CompletedNCT05506176
A Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19
A Multicenter, Randomized, Double-blind, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1,208 (actual)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase Ⅱ/Ⅲ study is to evaluate whether or not there is a difference in time recovery of COVID-19 signs and symptoms through Day 29 between SIM0417/ritonavir and placebo.
Detailed description
The efficacy, safety, and tolerability of SIM0417/ritonavir compared to placebo will be investigated. The exposure to SIM0417 in this population will also be investigated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SIM0417 | dose of 750 mg SIM0417 with 100 mg ritonavir. |
| DRUG | Placebo | Placebo (tablet) |
Timeline
- Start date
- 2022-08-19
- Primary completion
- 2023-01-23
- Completion
- 2023-03-21
- First posted
- 2022-08-18
- Last updated
- 2023-05-06
Locations
35 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05506176. Inclusion in this directory is not an endorsement.